Product Code: MGP FDA unclassified

Dressing, Wound And Burn, Occlusive

Unknown

The occlusive wound and burn dressing carries an unclassified (Class U) FDA designation, meaning its classification has not been formally determined. It is a wound care device that creates a moist, sealed environment over wounds and burns to promote healing and protect against environmental contamination. The product code is MGP and no regulation number or formal medical specialty has been assigned. It is not implanted and does not sustain life.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MGP
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K012997	COLLATEK FOAM	Oct 25, 2001	Substantially Equivalent	Biocore Medical Technologies, Inc.
K012995	COLLATEK SHEET	Oct 25, 2001	Substantially Equivalent	Biocore Medical Technologies, Inc.
K001508	LASERSKIN DRESSING	Jul 25, 2001	Substantially Equivalent	Fidia Advanced Biopolymers Srl
K990079	FASTSEAL CHEST WOUND DRESSING	Dec 23, 1999	Substantially Equivalent	Greenfield Medical Technologies, Inc.
K991214	SIMPLICARE TRANSPARENT WOUND DRESSING	Oct 14, 1999	Substantially Equivalent	Hollister, Inc.
K992302	DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS	Sep 14, 1999	Substantially Equivalent	Dermaphylyx, Inc.
K992005	GILTECH PLUS TRANSPARENT DRESSING	Sep 03, 1999	Substantially Equivalent	Giltech Plus, Inc.
K990875	DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING	May 27, 1999	Substantially Equivalent for Some Indications	Dermaphylyx, Inc.
K990438	DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING	Mar 25, 1999	Substantially Equivalent	Dermaphylyx, Inc.
K984371	MEPITEL NON ADHERENT SILICONE DRESSING	Mar 03, 1999	Substantially Equivalent	Molnlycke Health Care, Inc.
K983303	INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS	Dec 09, 1998	Substantially Equivalent	Innovative Technologies , Ltd.
K983234	TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING	Nov 25, 1998	Substantially Equivalent	Johnson & Johnson Medical, Div. of Ethicon, Inc.
K983394	MODIFICATION TO TIELLE HYDROPOLMER DRESSING	Nov 03, 1998	Substantially Equivalent	Johnson & Johnson Medical, Div. of Ethicon, Inc.
K983184	MEPILEX	Oct 28, 1998	Substantially Equivalent	Molnlycke Health Care, Inc.
K974891	ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013	Oct 21, 1998	Substantially Equivalent	Acutek Adhesive Specialties, Inc.
K982939	BTF THIN FILM WOUND DRESSING	Oct 13, 1998	Substantially Equivalent	Bioderm, Inc.
K974892	ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012	Oct 13, 1998	Substantially Equivalent	Acutek Adhesive Specialties, Inc.
K974890	ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002	Oct 13, 1998	Substantially Equivalent	Acutek Adhesive Specialties, Inc.
K981713	CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0	Jul 31, 1998	Substantially Equivalent	Smith & Nephew, Inc.
K981753	INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING	Jun 30, 1998	Substantially Equivalent	Innovative Technologies , Ltd.
K980209	SIMPLICARE THIN FILM WOUND DRESSINGS	Feb 20, 1998	Unknown	Hollister, Inc.
K974520	SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM	Feb 06, 1998	Substantially Equivalent	Innovative Technologies (Us), Inc.
K973538	N-TERFACE	Dec 16, 1997	Substantially Equivalent for Some Indications	Winfield Laboratories, Inc.
K973657	ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING	Dec 01, 1997	Substantially Equivalent for Some Indications	Maersk Medical, Ltd.
K973036	3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES	Nov 12, 1997	Substantially Equivalent for Some Indications	3M Healthcare
K964398	SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED	Oct 24, 1997	Substantially Equivalent	Polymedica Industries, Inc.
K973312	TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING	Oct 22, 1997	Substantially Equivalent	Innovative Technologies , Ltd.
K973260	HYDRASORB STERILE DRESSING	Oct 21, 1997	Substantially Equivalent	Avitar, Inc.
K972458	LYOCELL WOUND DRESSING/SURGICAL SPONGE	Sep 19, 1997	Substantially Equivalent	Courtaulds Fibers, Inc.
K971093	OPPORTUNITY I.V. START KIT	Sep 16, 1997	Substantially Equivalent for Some Indications	Opportunity, Inc.
K970518	ALGOPLAQUE HYDROCOLLOID DRESSING	Mar 21, 1997	Substantially Equivalent for Some Indications	Laboratoires Urgo S.A.
K963753	NASP TRANSPARENT DRESSING	Nov 29, 1996	Substantially Equivalent	North American Sterilization & Packaging Co.
K963623	SPYROFLEX PIGMENTED WOUND DRESSING	Oct 25, 1996	Substantially Equivalent	Polymedica Industries, Inc.
K961319	EPIVIEW	Jul 08, 1996	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K961098	BIO-DRESSING, STERILE ISLAND DRESSING	May 03, 1996	Substantially Equivalent for Some Indications	K. W. Griffen Co.
K960847	DERMASEAL	Apr 04, 1996	Substantially Equivalent	Bellingham Medical, Inc.
K960404	SURESKIN THIN	Mar 01, 1996	Substantially Equivalent for Some Indications	Euromed A/S
K960394	SURESKIN STANDARD	Mar 01, 1996	Substantially Equivalent for Some Indications	Euromed A/S
K960393	SURESKIN BORDER	Mar 01, 1996	Substantially Equivalent for Some Indications	Euromed A/S
K955476	DUKAL TRANSPARENT WOUND DRESSING	Jan 18, 1996	Substantially Equivalent for Some Indications	Dukal Corp.
K955383	SPYROCOLLOID WOUND DRESSING	Dec 13, 1995	Substantially Equivalent for Some Indications	Polymedica Industries, Inc.
K953885	SPYROFLEX SKIN PROTECTOR	Nov 29, 1995	Substantially Equivalent	Polymedica Industries, Inc.
K954738	DERMAGRAN HYDROPHILIC WOUND DRESSING	Nov 02, 1995	Substantially Equivalent	Derma Sciences, Inc.
K954602	FLEXZAN WOUND DRESSING	Nov 02, 1995	Substantially Equivalent for Some Indications	Dow Hickam Pharmaceuticals, Inc.
K954033	TECNOL ISLAND WOUND DRESSING	Sep 22, 1995	Substantially Equivalent for Some Indications	Tecnol Medical Products, Inc.
K953018	UNI-SITE	Sep 08, 1995	Substantially Equivalent	Ttl Medical
K953618	SPYROFLEX WOUND DRESSING	Aug 21, 1995	Substantially Equivalent for Some Indications	Polymedica Industries, Inc.
K952449	TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING	Aug 07, 1995	Substantially Equivalent	Medical Device Development Co.
K952504	TECNOL TRANSPARENT WOUND DRESSING	Jul 26, 1995	Substantially Equivalent for Some Indications	Tecnol Medical Products, Inc.
K952217	MITRAFLEX WOUND DRESSING WET-STICK	Jun 22, 1995	Substantially Equivalent	Polymedica Industries, Inc.
K952071	ULTEC THIN HYDROCOLLOID DRESSING	Jun 22, 1995	Substantially Equivalent	Sherwood Medical Co.
K951842	BIODERM MEDICAL TRANSPARENT FILM DRESSING	Jun 12, 1995	Substantially Equivalent	Bioderm, Inc.
K946338	CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING	Mar 29, 1995	Substantially Equivalent	Certified Safety Mfg., Inc.
K945977	CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING	Mar 29, 1995	Substantially Equivalent	Tri-State Hospital Supply Corp.
K950065	CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS	Mar 24, 1995	Substantially Equivalent	Conmedcorp
K943363	CUTIPLAST STERIL	Mar 15, 1995	Substantially Equivalent	Beiersdorf, Inc.
K946292	BIODERM MEDICAL COMPOSITE WOUND DRESSING	Feb 06, 1995	Substantially Equivalent	Bioderm, Inc.
K941790	PRO-TECT SAFETY DRESSING	Jan 12, 1995	Substantially Equivalent	Pro-Tect Medical Products, Inc.
K941789	PRO-TECT TRAUMA PAK	Jan 12, 1995	Substantially Equivalent	Pro-Tect Medical Products, Inc.
K940895	EPIVIEW	Nov 22, 1994	Substantially Equivalent for Some Indications	Convatec, A Bristol-Myers Squibb Co.
K943424	CUSH ISLAND DRESSING	Oct 03, 1994	Substantially Equivalent for Some Indications	Cush Medical Products
K943111	TRANSPARENT DRESSING	Sep 12, 1994	Substantially Equivalent for Some Indications	Acutek Adhesive Specialties, Inc.
K943280	PROCEL BURN COVER/PROCEL BURN TREATMENT COVER	Aug 18, 1994	Substantially Equivalent for Some Indications	W.L. Gore & Company, GmbH
K942757	ASHERMAN CHEST BANDAGE	Aug 01, 1994	Substantially Equivalent for Some Indications	Asherman Medical Products, LLC
K942774	POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING	Jul 20, 1994	Substantially Equivalent for Some Indications	The Kendal Co.
K935796	HYDRODERM BREATHABLE TRANSPARENT DRESSING	Feb 02, 1994	Substantially Equivalent	Wilshire Medical Products
K926399	CUTIFILM(R) FILM	Nov 15, 1993	Substantially Equivalent	Beiersdorf, Inc.
K931599	HYDRASORB STERILE DRESSING	Jul 08, 1993	Substantially Equivalent	Calgon Vestal Div.
K930401	ALUMINUM FOIL	May 12, 1993	Substantially Equivalent	Gam Industries, Inc.
K926034	EPI-LOCK WOUND DRESSING	Apr 20, 1993	Substantially Equivalent	Calgon Vestal Div.
K925660	KTI TRANSPARENT WOUND DRESSING	Apr 20, 1993	Substantially Equivalent	Kingston Technologies, Inc.
K924008	STERILE FILM WOUND DRESSING	Nov 24, 1992	Substantially Equivalent for Some Indications	Innovative Technology , Ltd.
K923150	SILON TRANSPARENT WOUND DRESSINGS	Aug 27, 1992	Substantially Equivalent	Bio Med Sciences, Inc.
K920796	DEROYAL TRANSPARENT FILM DRESSIGN	Jul 23, 1992	Substantially Equivalent	Deroyal Industries, Inc.
K915695	PROCEL BURN COVER	May 29, 1992	Substantially Equivalent for Some Indications	W. L. Gore & Associates, Inc.
K915635	CURITY VENTED DRESSING SYSTEM	Jan 31, 1992	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K912032	SILON(TM) TRANSPARENT WOUND DRESSING	Aug 20, 1991	Substantially Equivalent	Bio Med Sciences, Inc.
K911649	MITRASHEER TRANSPLANT DRESSING	Aug 07, 1991	Substantially Equivalent	Polymint Industrial Co. , Ltd.
K911161	INERPAN(TM) TEMPORARY WOUND DRESSING	Jun 27, 1991	Substantially Equivalent for Some Indications	Laboratories Delalande
K911660	INTRASITE HYDROCOLLOID WOUND DRESSING	Jun 17, 1991	Substantially Equivalent	Smith & Nephew United, Inc.